Summary of Package Insert 1 for Apligraf

Transcription

1 Summary of Package Insert 1 for Apligraf For States with Non-Published Policies NGS Indications Non-infected partial and full-thickness skin ulcers due to VSU 2 of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. Full-thickness neuropathic DFU 3 of greater than 3 weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure. Limitations The safety and effectiveness of Apligraf have not been established for patients receiving greater than 5 device applications. Coding CPT/HCPCS 1,4 Q4101: Apligraf, per square centimeter JW Modifier: Efffective January 1, In the Physician Office Setting, POS 11. Claims for discarded drug or biological amount not administered to any patient, shall be submitted using the JW modifier. This modifier, billed on a separate line, will provide payment for the amount of discarded drug or biological. Providers must document the discarded drugs or biologicals in patient's medical record. Application Codes for Leg 15271: Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area 15272: Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) 15273: Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area 15274: Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) Application Codes for Foot 15275: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25

2 Summary of Package Insert 1 for Apligraf (continued) sq cm or less wound surface area 15276: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) 15277: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area 15278: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) 1 This document is for informational purposes only. Use of this information does not guarantee coverage or payment for these services by Medicare or other payors. Physicians and other providers should use independent judgment when selecting codes that most appropriately describe the services provided to a patient. Physicians and hospitals are solely responsible for compliance with Medicare and other payors laws, rules, and requirements. 2 VSU = Venous Stasis Ulcer. 3 DFU = Diabetic Foot Ulcer. 4 CPT American Medical Association. All Rights Reserved.

3 2017 NGS Medicare / No Formal Policy Apligraf Sample UB-04 Claim Form Hospital 123 Medical Drive, NJ HIC A Maple Avenue NJ All dates should be in eight digit format. Jane Smith 111 Maple Avenue, NJ Apligraf Q Application, first 25 sq cm Application, each additional 25 sq cm Enter appropriate revenue codes for all services provided. Revenue code 636 should be used when billing for Apligraf and should be used based on the size of the wound. For example, a LEG wound measuring 40 sq cm, would be billed using (first 25 sq cm or less) and (each additional 25 sq cm or part thereof). Apligraf is supplied in 44 sq cm. Apligraf is FDA approved for single use only. Medicare A xxx.xx Please refer to Codes Commonly Used when Billing for Apligraf for appropriate diagnosis codes and your specific payer s requirements.

4 2017 NGS Medicare / No Formal Policy Apligraf Sample CMS-1500 Claim Form Physician Services in an Outpatient Setting A (973) SIGNATURE ON FILE Please refer to Codes Commonly Used when Billing for Apligraf for appropriate diagnosis codes and your specific payer s requirements and should be used based on the size of the wound. For example, a LEG wound measuring 40 sq cm, would be billed using (first 25 sq cm or less) and (each additional 25 sq cm or part thereof)

5 2017 NGS Medicare / No Formal Policy Apligraf Sample CMS-1500 Claim Form Physician Services in an Office Setting A (973) SIGNATURE ON FILE Please refer to Codes Commonly Used when Billing for Apligraf for appropriate diagnosis codes and your specific payer s requirements Q Q4101 JW sq cm of the product was used on the wound. 4 sq cm of product was discarded and documented as wastage and therefore billed with a JW Modifier and should be used based on the size of the wound. For example, a LEG wound measuring 40 sq cm, would be billed using (first 25 sq cm or less) and (each additional 25 sq cm or part thereof). 4 1 Apligraf is supplied in 44 sq cm. Apligraf is FDA approved for single use only

6 Model Documentation Form for National Government Services / Summary of Package Insert for Apligraf Pretreatment: 1. Duration of ulcer (DFU: 3 weeks, VSU: greater than 1 month) weeks 2. Document failure to respond to conservative measures (a failed response is defined as an ulcer that has increased in size or depth and no indication that improvement is likely e.g., epithelial in growth and progression towards closure) 3. Document measurement of the ulcer at baseline, following cessation of conservative management. 4. Describe adequate treatment of the underlying disease process contributing to the ulcer 5. Diagnosis of patient 6. Document that wound is free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and tracts, eschar or any necrotic material 7. For DFU, document current HbA1C reading (HbA1C should not exceed 12%) 8. Document adequate arterial blood supply as evidenced by an ABI of 0.65 or greater Treatment: 9. Document measurement of ulcer (width and length or circumference and depth) immediately prior to application of Apligraf sq cm 10. Document whether this is an initial application of Apligraf or a reapplication. (Apligraf is limited to 5 applications per ulcer) 11. For Apligraf reapplications, document that applications have been successful (e.g. decrease in size or depth, increase in granulation tissue) 12. Document the wound dressing changes and the standard conservative measures accompanying the wound treatment with Apligraf This document is for informational purposes only. Use of this information does not guarantee coverage or payment for these services by Medicare or other payors. LCDs are updated by Medicare and Medicare contractors on a regular basis. Physicians and other providers should regularly refer to the applicable Medicare local coverage determinations (LCDs) for complete information on medical necessity documentation requirements. Physicians, providers and hospitals are solely responsible for compliance with Medicare and other payors laws, rules, and requirements.

7 13. Document how the wound site was prepared, and how Apligraf was fixated on the wound. Product Wastage Documentation Requirements: 14. Date and Time: 15. Location of ulcer: 16. Approximate amount of product unit used: 17. Approximate amount of product unit discarded: 18. Reason for the wastage: 19. Manufacture s serial/lot/batch number Modifiers: JW- Skin substitute not applied to wound, wastage. The JW modifier is only applied to the amount of drug or biological that is discarded. This document is for informational purposes only. Use of this information does not guarantee coverage or payment for these services by Medicare or other payors. LCDs are updated by Medicare and Medicare contractors on a regular basis. Physicians and other providers should regularly refer to the applicable Medicare local coverage determinations (LCDs) for complete information on medical necessity documentation requirements. Physicians, providers and hospitals are solely responsible for compliance with Medicare and other payors laws, rules, and requirements.